FOSRENOL (lanthanum carbonate)
Fosrenol helps patients with end-stage renal disease manage high levels of phosphate in their blood. It is used as part of a broader management plan that typically includes dietary changes and dialysis. By lowering serum phosphate and calcium phosphate levels, this medication helps address a common complication of advanced kidney failure.
How FOSRENOL Works
This medication works by binding to phosphate in the digestive tract to form insoluble complexes. These complexes pass through the body without being absorbed, which prevents dietary phosphate from entering the bloodstream. This process effectively lowers both serum phosphate and calcium phosphate levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-10-26
- PDUFA Date
- 2026-06-29 (34d)
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- POWDER, TABLET, CHEWABLE
FOSRENOL Approval History
What FOSRENOL Treats
1 indicationsFOSRENOL is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- End-Stage Renal Disease
FOSRENOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FOSRENOL
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03136705 results posted | STU00090161 | Ph 1 | completed | Healthy Combine Study |
| NCT02209636 results posted | CLNB-006-13F CX001030 | Ph 4 | completed | Phosphate Lowering in CKD Trial |
| NCT02258074 COMBINE results posted | DK099877-C U01DK099877 | Ph 2 | completed | The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE |
| NCT03451019 | S-L2018 | Ph 4 | completed | Different Effects of Non-calcium Phosphate Binders on Serum Calcium |
| NCT00875017 results posted | SPD405-128 | Ph 1 | completed | Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers |
| NCT01696279 results posted | SPD405-207 2012-000171-17 | Ph 2 | completed | A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis |
| NCT01128179 results posted | SPD405-703 2009-016531-35 | Ph 2 | completed | Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD |
| NCT01578200 LANDMARK | TRIGU1111 UMIN000006815 | Ph 3 | completed | Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study |
| NCT01289626 | H-2010-0127 | Ph 1 | completed | Efficacy of Lanthanum Carbonate in Calciphylaxis |
| NCT00841126 | ACT 401 2008-004729-41 | Ph 3 | terminated | Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOSRENOL FDA Label Details
Indications & Usage
FDA Label (PDF)FOSRENOL is indicated for the treatment of End-Stage Renal Disease.
Pro Intelligence Preview
Deep insights for FOSRENOL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 8 active patents
Trial Analysis
- • 10 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment